Report Adverse Events Directly to the FDA MedWatch Program

Consumers and the Food and Drug Administration (FDA)

Consumers play an important public health role by reporting to the FDA any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product.

What is MedWatch?

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.

taking wrong dose of a drug because of confusing dosing instructions on label

4. Problem with different manufacturer of same medicine

not getting same results from a generic drug as a brand name drug, or from another generic

What is an adverse drug reaction?

An adverse drug reaction, also called a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.

Why should you report problems to the FDA?

In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these serious events. FDA uses the data to maintain the safety surveillance of products.

Your report may be the critical action that prompts a modification in the use or design of a product, improves its safety profile and leads to increased patient safety.

"Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval," says Norman Marks, M.D., Medical Director of FDA's MedWatch Program.

"Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death."

How can you report serious problems to MedWatch?

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.

However, the FDA understands that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.

You will receive an acknowledgement from FDA after your report is received. You will be personally contacted only if the FDA needs additional information.

There are three alternate routes for submitting an adverse event report: